Implantable heart valve devices, mitral valve repair devices and associated systems and methods

ABSTRACT

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a Continuation of U.S. patent applicationSer. No. 16/132,301, which is a Divisional of U.S. patent applicationSer. No. 14/892,171, now allowed, which is a 35 U.S.C. § 371 ofInternational Application No. PCT/US2014/038849, filed May 20, 2014,which claims priority to U.S. Provisional Patent Application No.61/825,491, filed May 20, 2013. Each of these applications isincorporated by reference in its entirety.

TECHNICAL FIELD

The present technology relates generally to implantable heart valvedevices. In particular, several embodiments are directed to mitral valvedevices for percutaneous repair of native mitral valves and associatedsystems and methods for repair and/or replacement of native mitralvalves.

BACKGROUND

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak systolic contraction pressures such that blood leaksabnormally from the left ventricle into the left atrium. There are anumber of structural factors that may affect the proper closure of themitral valve leaflets.

One structural factor that causes the mitral valve leaflet to separateis dilation of the heart muscle. FIG. 1A is a schematic illustration ofa native mitral valve showing normal coaptation between the anteriormitral valve leaflet (AMVL) and the posterior mitral valve leaflet(PMVL), and FIG. 1B is a schematic illustration of a native mitral valvefollowing a myocardial infarction which has dilated the ventricular freewall to an extent that mitral valve regurgitation has developed.Functional mitral valve disease is characterized by dilation of the leftventricle and a concomitant enlargement of the mitral annulus. As shownin FIG. 1B, the enlarged annulus separates the free edges of theanterior and posterior leaflets from each other such that the mitralleaflets do not coapt properly. The enlarged left ventricle alsodisplaces the papillary muscles further away from the mitral annulus.Because the chordae tendineae are of a fixed length, displacement of thepapillary displacement can cause a “tethering” effect that can alsoprevent proper coaptation of the mitral leaflets. Therefore, dilation ofthe heart muscle can lead to mitral valve regurgitation.

Another structural factor that can cause abnormal backflow iscompromised papillary muscle function due to ischemia or otherconditions. As the left ventricle contracts during systole, the affectedpapillary muscles do not contract sufficiently to effect proper closureof the valve. This in turn can lead to mitral valve regurgitation.

Treatment for mitral valve regurgitation has typically involved theapplication of diuretics and/or vasodilators to reduce the amount ofblood flowing back into the left atrium. Other procedures have involvedsurgical approaches (open and intravascular) for either the repair orreplacement of the valve. Replacement surgery, either done through largeopen thoracotomies or less invasively through a percutaneous approach,can be effective, but there are compromises of implanting a prostheticvalve. For example, prosthetic mechanical valves require a lifetime ofanticoagulation therapy and risks associated with stroke or bleeding.Additionally, prosthetic tissue valves have a finite lifetime,eventually wearing out, for example, over twelve or fifteen years.Therefore, valve replacement surgeries have several shortcomings.

Mitral valve replacement also poses unique anatomical obstacles thatrender percutaneous mitral valve replacement significantly morechallenging than other valve replacement procedures, such as aorticvalve replacement. First, aortic valves are relatively symmetric anduniform, but in contrast the mitral valve annulus has a non-circularD-shape or kidney-like shape, with a non-planar, saddle-like geometryoften lacking symmetry. Such unpredictability makes it difficult todesign a mitral valve prosthesis having that properly conforms to themitral annulus. Lack of a snug fit between the prosthesis and the nativeleaflets and/or annulus may leave gaps therein that allows backflow ofblood through these gaps. Placement of a cylindrical valve prosthesis,for example, may leave gaps in commissural regions of the native valvethat cause perivalvular leaks in those regions. Thus, the anatomy ofmitral valves increases the difficulty of mitral valve replacementprocedures and devices.

In addition to its irregular, unpredictable shape, which changes sizeover the course of each heartbeat, the mitral valve annulus lacks radialsupport from surrounding tissue. The aortic valve, for example, iscompletely surrounded by fibro-elastic tissue that provides good supportfor anchoring a prosthetic valve at a native aortic valve. The mitralvalve, on the other hand, is bound by muscular tissue on the outer wallonly. The inner wall of the mitral valve is bound by a thin vessel wallseparating the mitral valve annulus from the inferior portion of theaortic outflow tract. As a result, significant radial forces on themitral annulus, such as those imparted by an expanding stent prostheses,could lead to impairment of the inferior portion of the aortic tract.

Typical mitral valve repair approaches have involved cinching orresecting portions of the dilated annulus. Cinching of the annulus hasbeen accomplished by implanting annular or peri-annular rings that aregenerally secured to the annulus or surrounding tissue. Other repairprocedures have also involved suturing or clipping of the valve leafletsinto partial apposition with one another. For example, the Evalve(Abbott Vascular) MitraClip® clips the two mitral valve leafletstogether in the region where the leaflets fail to coapt to therebyreduce or eliminate regurgitation. Mitral valve repair surgery hasproven effective, and especially for patients with degenerative disease.Repair surgery typically involves resecting and sewing portions of thevalve leaflets to optimize their shape and repairing any torn chordaetendineae, and such surgeries usually include placement of anannuloplasty ring to shrink the overall circumference of the annulus ina manner that reduces the anterior-posterior dimension of the annulus.

Efforts to develop technologies for percutaneous mitral annuloplastythat avoid the trauma, complications, and recovery process associatedwith surgery, have led to devices and methods for cinching the annulusvia the coronary sinus, or cinching the annulus via implantation ofscrews or anchors connected by a tensioned suture or wire. In operation,the tensioned wire draws the anchors closer to each other to cinch(i.e., pull) areas of the annulus closer together. Additional techniquesproposed previously include implanting paired anchors on the anteriorand posterior areas of the annulus and pulling them together, and usingRF energy to shrink the annular tissue among other approaches.

However, all of these percutaneous annuloplasty approaches have eludedmeaningful clinical or commercial success to date, at least partly dueto the forces required to change the shape of the native annulus, whichis relatively stiff and is subject to significant loads due toventricular pressure. Furthermore, many of the surgical repairprocedures are highly dependent upon the skill of the cardiac surgeonwhere poorly or inaccurately placed sutures may affect the success ofprocedures. Overall, many mitral valve repair and replacement procedureshave limited durability due to improper sizing or valve wear.

Given the difficulties associated with current procedures, there remainsthe need for simple, effective, and less invasive devices and methodsfor treating dysfunctional heart valves, for example, in patientssuffering functional mitral valve disease.

SUMMARY

At least some embodiments are directed to a method of repairing a nativemitral valve having an anterior leaflet and a posterior leaflet betweena left atrium and a left ventricle. A repair device having a support canbe implanted under the posterior leaflet. The support can be pressedagainst a portion of an underside of the posterior leaflet and therebypush at least a portion of the posterior leaflet toward the anteriorleaflet.

In some embodiments, a method of repairing a native mitral valve havingan anterior leaflet and a posterior leaflet between a left atrium and aleft ventricle includes positioning a repair device in the leftventricle under the posterior leaflet and between a wall of the leftventricle and chordae tendineae. The repair device can engage anunderside of the posterior leaflet such that a portion of the posteriorleaflet moves toward the anterior leaflet.

At least some embodiments are directed to a method for repairing anative valve of a patient and includes positioning a heart valve repairdevice in a subannular position behind at least one leaflet connected tochordae tendineae. The repair device has a support in an unexpandedconfiguration. The support in the subannular position is expanded suchthat the support engages an interior surface of a heart wall and adownstream-facing surface of the leaflet. The repair device isconfigured to reposition the leaflet into an at least partially closedposition and brace the leaflet to affect native valve function. In someembodiments, the repair device is configured to improve function of thenative valve by bracing the leaflet.

In some embodiments, a repair device for repairing a native mitral valvehaving an anterior leaflet and a posterior leaflet between a left atriumand a left ventricle comprises a support having (a) a contractedconfiguration in which the support is sized to be inserted under theposterior leaflet between a wall of the left ventricle and chordaetendineae and (b) an extended configuration in which the supportprojects anteriorly with respect to a posterior wall of the leftventricle by a distance sufficient to position at least a portion of theposterior leaflet toward the anterior leaflet sufficiently to improvecoaptation of the posterior and anterior leaflets.

In some embodiments, a heart valve repair device to treat a native valveof a patient comprises a support implantable in a subannular positionrelative to the native valve. The support can be configured to engage aninterior surface of a heart wall and an outward-facing surface of aleaflet of the native valve in the subannular position such that thesupport repositions the leaflet into a desired position (e.g., at leastpartially closed position).

In further embodiments, a heart valve repair device to treat a nativevalve of a patient comprises a frame have a first end configured to beplaced at least proximate a first commissure of the native valve, asecond end configured to be placed at least proximate a secondcommissure of the native valve, and a curved region between the firstand second ends. The curved region of the frame is configured to engagea backside of a leaflet of the native heart valve so as to repositionthe leaflet such that the leaflet at least partially coapts with anadjacent leaflet of the native valve.

In some embodiments, a system to treat a native valve of a patientcomprises a prosthetic valve repair device implantable in a subannularposition relative to the native valve. The repair device includes asupport configured to engage an interior surface of a heart wall and anoutward-facing surface of a leaflet of the native valve in a subannularposition of the native valve. The support is configured to change aneffective annulus shape and/or an effective annulus cross-sectionaldimension when the device is in a deployed configuration. In certainembodiments, the system further includes a prosthetic valve having aradially expandable support structure with a lumen and a valve in thelumen and coupled to the support structure. The radially expandablesupport structure is configured to be deployed within the native valvewhen the prosthetic valve repair device is implanted in the subannularposition and supported within the changed annulus shape or changedannulus cross-sectional dimension.

At least some embodiments are directed to a valve repair device thatcomprises means for supporting a posterior leaflet. The means forsupporting the posterior leaflet has contracted configuration forinsertion under the posterior leaflet between a wall of the leftventricle and chordae tendineae and an extended configuration forprojecting anteriorly with respect to a posterior wall of the leftventricle. In one embodiment, the means for supporting extends adistance sufficient to position at least a portion of the posteriorleaflet toward the anterior leaflet to affect coaptation of theposterior and anterior leaflets. In one embodiment, the means forsupporting includes one or more extensions units expandable using one ormore filler materials. The means for supporting can further include anelongated spine coupled to the extension unit(s).

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIG. 1A is a schematic illustration of a native mitral valve showingnormal coaptation between the anterior mitral valve leaflet and theposterior mitral valve leaflet.

FIG. 1B is a schematic illustration of a native mitral valve followingmyocardial infarction which has caused the ventricular free wall todilate, and wherein mitral valve regurgitation has developed.

FIGS. 2 and 3 are schematic illustrations of a mammalian heart havingnative valve structures.

FIG. 4 is a schematic cross-sectional side view of a native mitral valveshowing the annulus and leaflets.

FIG. 5 is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for combination with variousprosthetic heart valve repair devices in accordance with embodiments ofthe present technology.

FIG. 6A is a schematic illustration of a native mitral valve of a heartshowing normal closure of native mitral valve leaflets.

FIG. 6B is a schematic illustration of a native mitral valve of a heartshowing abnormal closure of native mitral valve leaflets in a dilatedheart, and which is suitable for combination with various prostheticheart valve repair devices in accordance with embodiments of the presenttechnology.

FIG. 6C is a schematic illustration of a mitral valve of a heart showingdimensions of the annulus, and which is suitable for combination withvarious prosthetic heart valve repair devices in accordance withembodiments of the present technology.

FIGS. 7 and 8 are schematic cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 9 is a schematic cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 10A is a schematic cross-sectional illustration of the heartshowing an antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 10B is a schematic cross-sectional illustration of the heartshowing access through the inter-atrial septum (IAS) maintained by theplacement of a guide catheter over a guidewire in accordance withvarious embodiments of the present technology.

FIG. 11A is a cross-sectional top view of a prosthetic heart valverepair device in an expanded configuration in accordance with anembodiment of the present technology.

FIG. 11B is a cross-sectional side view of a prosthetic heart valverepair device in an expanded configuration in accordance with anembodiment of the present technology.

FIG. 11C is a cross-sectional side view of a prosthetic heart valverepair device in a contracted configuration in accordance with anembodiment of the present technology.

FIG. 12A is a cross-sectional top view of a prosthetic heart valverepair device and a delivery system at a stage of implanting theprosthetic heart repair valve device in accordance with an embodiment ofthe present technology.

FIG. 12B is a cross-sectional top view of the prosthetic heart valverepair device and delivery system of FIG. 12A at a subsequent stage ofimplanting the prosthetic heart repair valve device in accordance withan embodiment of the present technology.

FIG. 13 is a cross-sectional view schematically illustrating a leftatrium, left ventricle, and native mitral valve of a heart with anembodiment of a prosthetic heart valve repair device implanted in thenative mitral valve region in accordance with an embodiment of thepresent technology.

FIG. 14 is a cross-sectional view schematically illustrating a portionof a left atrium, left ventricle, and native mitral valve of a heartwith an embodiment of a prosthetic heart valve repair device implantedin the native mitral valve region in accordance with an embodiment ofthe present technology.

FIG. 15 is a cross-sectional view schematically illustrating a portionof a left atrium, left ventricle, and native mitral valve of a heartwith an embodiment of a prosthetic heart valve repair device implantedin the native mitral valve region in accordance with an embodiment ofthe present technology.

FIGS. 16A and 16B are cross-sectional views schematically illustrating aportion of a left atrium, left ventricle, and native mitral valve of aheart with an embodiment of a prosthetic heart valve repair deviceimplanted in the native mitral valve region in accordance with anembodiment of the present technology.

FIGS. 17A-17C are schematic top views of a native mitral valve in theheart viewed from the left atrium and showing a heart valve repairdevice implanted at the native mitral valve in accordance withadditional embodiments of the present technology.

FIG. 18 is a perspective view of a prosthetic heart valve repair devicein an expanded configuration in accordance with another embodiment ofthe present technology.

FIG. 19 is a cross-sectional view schematically illustrating a leftatrium, left ventricle, and native mitral valve of a heart with aprosthetic heart valve repair device implanted in the native mitralvalve region in accordance with an embodiment of the present technology.

FIG. 20A is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing normal closure of native mitralvalve leaflets.

FIG. 20B is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing abnormal closure of nativemitral valve leaflets, and which is suitable for combination withvarious prosthetic heart valve repair devices in accordance withembodiments of the present technology.

FIG. 20C is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing a heart valve repair deviceimplanted at the native mitral valve in accordance with an embodiment ofthe present technology.

FIG. 21A is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing a heart valve repair deviceimplanted at the native mitral valve in accordance with a furtherembodiment of the present technology.

FIG. 21B is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing a heart valve repair deviceimplanted at the native mitral valve in accordance with anotherembodiment of the present technology.

FIG. 21C is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing the heart valve repair device ofFIG. 21A and a prosthetic heart valve implanted at the native mitralvalve in accordance with an embodiment of the present technology.

FIG. 22 illustrates a method for repairing a native valve of a patientin accordance with an embodiment of the present technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1A-22. Although many of the embodimentsare described below with respect to devices, systems, and methods forpercutaneous repair of a native mitral valve using prosthetic heartvalve repair devices, other applications and other embodiments inaddition to those described herein are within the scope of thetechnology. Additionally, several other embodiments of the technologycan have different configurations, components, or procedures than thosedescribed herein. A person of ordinary skill in the art, therefore, willaccordingly understand that the technology can have other embodimentswith additional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1A-22.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a heart valve repair device and/oran associated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various heart valverepair or replacement devices described herein, “proximal” can refer toa position closer to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve repair or replacement device, the terms“proximal” and “distal” can refer to the location of portions of thedevice with respect to the direction of blood flow. For example,proximal can refer to an upstream-oriented position or a position ofblood inflow, and distal can refer to a downstream-oriented position ora position of blood outflow.

Additionally, the term “expanded configuration” refers to theconfiguration or state of the device when allowed to freely expand to anunrestrained size without the presence of constraining or distortingforces. The terms “deployed configuration” or “deployed” refer to thedevice after expansion at the native valve site and subject to theconstraining and distorting forces exerted by the native anatomy. Theterms “extended configuration” or “extended state” refer to the“expanded configuration and/or deployed configuration,” and the terms“contracted configuration” or “contracted state” refer to the device ina compressed or otherwise collapsed state.

For ease of reference, throughout this disclosure identical referencenumbers and/or letters are used to identify similar or analogouscomponents or features, but the use of the same reference number doesnot imply that the parts should be construed to be identical. Indeed, inmany examples described herein, the identically numbered parts aredistinct in structure and/or function. The headings provided herein arefor convenience only.

Overview

Systems, devices and methods are provided herein for percutaneous repairof native heart valves, such as mitral valves. Several of the detailsset forth below are provided to describe the following examples andmethods in a manner sufficient to enable a person skilled in therelevant art to practice, make and use them. Several of the details andadvantages described below, however, may not be necessary to practicecertain examples and methods of the technology. Additionally, thetechnology may include other examples and methods that are within thescope of the claims but are not described in detail.

Embodiments of the present technology provide systems, methods andapparatus to treat valves of the body, such as heart valves includingthe mitral valve. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart. Additionally, the apparatus and methods enableother less-invasive approaches including trans-apical, trans-atrial, anddirect aortic delivery of a heart valve repair device to a targetlocation in the heart. The apparatus and methods enable a prostheticdevice to be anchored at or near a native valve location by engaging asubannular surface and other sub-valvular elements of the valve annulus,chordae tendineae, and/or valve leaflets. Additionally, the embodimentsof the devices and methods described herein can be combined with manyknown surgeries and procedures, such as known methods of accessing thevalves of the heart (e.g., the mitral valve or tricuspid valve) withantegrade or retrograde approaches, and combinations thereof.

The devices and methods described herein provide a valve repair devicethat has the flexibility to adapt and conform to the variably-shapednative mitral valve anatomy while physically supporting or bracing(e.g., pushing) the posterior leaflet of the mitral valve toward theanterior leaflet in at least a partially closed position to facilitatecoaptation of the native mitral leaflets during systole. Severalembodiments of the device effectively reduce the size of the mitralorifice and render the native mitral valve competent. The device has thestructural strength and integrity necessary to withstand the dynamicconditions of the heart over time and to permanently anchor the repairdevice in the subannular position so that the patient can resume asubstantially normal life. The systems and methods further deliver sucha device in a less-invasive manner to provide a patient with a new,permanent repair device using a lower-risk procedure that has a fasterrecovery period compared to conventional procedures.

Several embodiments of the present technology include devices forrepairing a native valve of a heart. Native heart valves have an annulusand leaflets, and such repair devices include a support for engaging aninterior surface of a heart wall and an outward-facing surface (e.g., abackside, underside or downstream side) of a leaflet of the native valvein a subannular position of the native valve. The device can beconfigured to support the leaflet in an at least partially closedposition. In the at least partially closed position the leaflet can bepositioned so that valve function is improved, usually by improving thecoaptation of the leaflets. For example, in the at least partiallyclosed position the leaflet can be held closer to an opposing leaflet ofthe native valve such that the two leaflets coapt, or sealingly engagewith one another, through a portion of the cardiac cycle. The leafletmay be positioned so that a portion of the leaflet—which may be the freeedge of the leaflet or a mid-portion of the leaflet—coapts with asurface of the opposing leaflet with which the leaflet did not coaptprior to treatment. The device can have a support that optionally caninclude a spine or beam and an extension unit coupled to or extendingfrom or around the spine. In one embodiment, the extension unit caninclude a biocompatible material suitable to support tissue ingrowth. Invarious embodiments, the extension unit can include a plurality ofprojections configured to expand or otherwise extend between and/orengage chordae tendineae associated with the leaflet. In someembodiments, the extension unit comprises a flexible, fluid-impermeablecover, such as an inflatable bladder or balloon, and an injectablefiller material within the cover that expands portions of the extensionunit and maintains the expanded configuration over time (e.g., fillingand expanding the plurality of projections).

Some embodiments of the disclosure are directed to systems to repair anative valve of a patient and implant a prosthetic valve. In oneembodiment, the system can have a prosthetic heart valve repair deviceimplantable in a subannular position relative to the native valve andhaving a support for engaging an interior surface of a heart wall and anoutward-facing surface (e.g., a backside, underside or downstream side)of a leaflet of the native valve in a subannular position of the nativevalve. In this embodiment, the support can be configured to change anannulus shape and/or an annulus cross-sectional dimension when thedevice is in a deployed configuration. For example, the support can beconfigured to change the annulus shape from a non-circular cross-sectionto a more circular or substantially circular cross-section. The systemcan also include a prosthetic heart valve. The prosthetic heart valvecan, for example, include a radially expandable support structure with alumen and a valve coupled to the support structure in the lumen. In thisarrangement, when the prosthetic heart valve repair device is implantedin the subannular position, the radially expandable support structurecan be supported within the changed annulus shape or changed annuluscross-sectional dimension. In a particular example, the heart valverepair device can be positioned behind a posterior mitral valve leafletin a subannular region, and the prosthetic heart valve can have asubstantially circular cross-sectional dimension.

Other aspects of the present technology are directed to methods forrepairing a native valve of a patient. In one embodiment, a methodincludes positioning a heart valve repair device in a subannularposition behind at least one leaflet connected to chordae tendineae. Therepair device can have a support that is initially in a contractedconfiguration. The method can also include expanding or otherwiseextending the support in the subannular position such that the supportengages an interior surface of a heart wall and an outward-facingsurface (e.g., a backside, underside or downstream side) of the leaflet.In one example, the native valve is a mitral valve and the support canengage a left ventricular wall and a posterior mitral valve leaflet. Inexemplary embodiments the support is extended toward a free edge of theleaflet, or toward an opposing leaflet with which the supported leafletshould coapt. In embodiments for mitral valve repair, the support may beextended in an anterior direction (i.e., away from a posterior wall ofthe ventricle and toward the anterior leaflet), or toward the anterioredge of the posterior leaflet. In various embodiments, the repair deviceis configured to support the leaflet in at least a partially closedposition to facilitate coaptation of the valve leaflets and therebyrepair the native valve. This coaptation may occur at the distal freeedges of one or both leaflets, or along a middle portion of one or bothleaflets.

Another embodiment of the disclosure is directed to a heart valve repairdevice to treat a native valve of a patient. In various arrangements,the repair device can comprise a frame having a first end configured tobe placed at least proximate a first commissure of the native valve anda second end configured to be placed at least proximate a secondcommissure of the native valve. The frame can further include a curvedregion between the first and second ends. The curved region of the framecan be configured to engage a backside of a leaflet of the native heartvalve such that the leaflet at least partially coapts with an adjacentleaflet of the native valve.

The devices and methods disclosed herein can be configured for treatingnon-circular, asymmetrically shaped valves and bileaflet or bicuspidvalves, such as the mitral valve. It can also be configured for treatingother valves of the heart such as the tricuspid valve. Many of thedevices and methods disclosed herein can further provide for long-term(e.g., permanent) and reliable anchoring of the prosthetic device evenin conditions where the heart or native valve may experience gradualenlargement or distortion.

Cardiac and Mitral Valve Physiology

FIGS. 2 and 3 show a normal heart H. The heart comprises a left atriumthat receives oxygenated blood from the lungs via the pulmonary veins PVand pumps this oxygenated blood through the mitral valve MV into theleft ventricle LV. The left ventricle LV of a normal heart H in systoleis illustrated in FIG. 3. The left ventricle LV is contracting and bloodflows outwardly through the aortic valve AV in the direction of thearrows. Back flow of blood or “regurgitation” through the mitral valveMV is prevented since the mitral valve is configured as a “check valve”which prevents back flow when pressure in the left ventricle is higherthan that in the left atrium LA. More specifically, the mitral valve MVcomprises a pair of leaflets having free edges FE which meet evenly, or“coapt” to close, as illustrated in FIG. 3. The opposite ends of theleaflets LF are attached to the surrounding heart structure via anannular region of tissue referred to as the annulus AN.

FIG. 4 is a schematic cross-sectional side view showing an annulus andleaflets of a mitral valve in greater detail. As illustrated, theopposite ends of the leaflets LF are attached to the surrounding heartstructure via a fibrous ring of dense connective tissue referred to asthe annulus AN, which is distinct from both the leaflet tissue LF aswell as the adjoining muscular tissue of the heart wall. The leaflets LFand annulus AN are comprised of different types of cardiac tissue havingvarying strength, toughness, fibrosity, and flexibility. Furthermore,the mitral valve MV may also comprise a unique region of tissueinterconnecting each leaflet LF to the annulus AN that is referred toherein as leaflet/annulus connecting tissue LAC (indicated byoverlapping cross-hatching).

Referring back to FIG. 3, the free edges FE of the mitral leaflets LFare secured to the lower portions of the left ventricle LV throughchordae tendineae CT which include a plurality of branching tendonssecured over the lower surfaces of each of the valve leaflets LF. Theprimary chordae CT in turn, are attached to the papillary muscles PM,which extend upwardly from the lower wall of the left ventricle LV andinterventricular septum IVS. Although FIG. 3 shows the primary chordaetendineae (CT) which connect the leaflets to the papillary muscles, theposterior leaflet of the mitral valve (as well as the leaflets of thetricuspid valve) also have secondary and tertiary chordae tendineaewhich connect the leaflets directly to the ventricular wall. Thesesecondary and tertiary chordae tendineae have a range of lengths andpositions, connecting to the leaflets at all heights, including close tothe leaflets' connection to the valve annulus. The secondary andtertiary chordae tendineae are illustrated in FIGS. 3, 5, 12, 13-16B and19, and described in further detail herein.

Referring now to FIG. 5, regurgitation can occur in patients sufferingfrom functional mitral valve disease (e.g., cardiomyopathy) where theheart is dilated, and the increased size prevents the valve leaflets LFfrom meeting properly. The enlargement of the heart causes the mitralannulus to become enlarged such that the free edges FE cannot meet(e.g., coapt) during systole. The free edges FE of the anterior andposterior leaflets normally meet along a line of coaptation C as shownin FIG. 6A, a view of the top or left atrial side of the valve, but asignificant gap G can be left in patients suffering from cardiomyopathy,as shown in FIG. 6B.

FIGS. 6A-6C further illustrates the shape and relative sizes of theleaflets L of the mitral valve. As shown in FIG. 6C, the overall mitralvalve has a generally “D”-shape or kidney-like shape, with a long axisMVA1 and a short axis MVA2. In healthy humans the long axis MVA1 istypically within a range from about 33.3 mm to about 42.5 mm in length(37.9+/−4.6 mm), and the short axis MVA2 is within a range from about26.9 to about 38.1 mm in length (32.5+/−5.6 mm). However, with patientshaving decreased cardiac function these values can be larger, forexample MVA1 can be within a range from about 45 mm to 55 mm and MVA2can be within a range from about 35 mm to about 40 mm. The line ofcoaptation C is curved or C-shaped such that the anterior leaflet AL islarger than the posterior leaflet PL (FIG. 6A). Both leaflets appeargenerally crescent-shaped from the superior or atrial side, with theanterior leaflet AL being substantially wider in the middle of the valvethan the posterior leaflet PL. As illustrated in FIG. 6A, at theopposing ends of the line of coaptation C, the leaflets join together atcorners called the anterolateral commissure AC and posteromedialcommissure PC.

FIG. 6C shows the shape and dimensions of the annulus of the mitralvalve. As described above, the annulus is an annular area around thecircumference of the valve comprised of fibrous tissue which is thickerand tougher than that of the leaflets LF and distinct from the musculartissue of the ventricular and atrial walls. The annulus may comprise asaddle-like shape with a first peak portion PP1 and a second peakportion PP2 located along an interpeak axis IPD, and a first valleyportion VP1 and a second valley portion VP2 located along an intervalleyaxis IVD. The first and second peak portion PP1 and PP2 are higher inelevation relative to a plane containing the nadirs of the two valleyportions VP1, VP2, typically being about 8-19 mm higher in humans, thusgiving the valve an overall saddle-like shape. The distance between thefirst and second peak portions PP1, PP2, referred to as interpeak spanIPD, is substantially shorter than the intervalley span IVD, thedistance between first and second valley portions VP1, VP2.

Referring back to FIG. 4, “subannular,” as used herein, refers to aportion of the mitral valve MV that lies on or downstream DN of theplane PO of the native orifice. As used herein, the plane PO of thenative valve orifice is a plane generally perpendicular to the directionof blood flow through the valve and which contains either or both themajor axis MVA1 or the minor axis MVA2 (FIG. 6C). Thus, a subannularsurface of the mitral valve MV is a tissue surface lying on theventricular side of the plane PO, and preferably one that facesgenerally downstream, toward the left ventricle LV. The subannularsurface may be disposed on the annulus AN itself or the ventricular wallbehind the native leaflets LF, or it may comprise an outward-facing ordownward-facing surface of the native leaflet OF, which lies below theplane PO. The subannular surface or subannular tissue may thus comprisethe annulus AN itself, the outward-facing surface OF of the nativeleaflets LF, leaflet/annulus connective tissue, the ventricular wall orcombinations thereof.

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the mitral valves may vary among patients, andalthough some patients may comprise differing physiology, the teachingsas described herein can be adapted for use by many patients havingvarious conditions, dimensions and shapes of the mitral valve. Forexample, work in relation to embodiments suggests that some patients mayhave a long dimension across the annulus and a short dimension acrossthe annulus without well-defined peak and valley portions, and themethods and device as described herein can be configured accordingly.

Access to the Mitral Valve

Access to the mitral valve or other atrioventricular valves can beaccomplished through the patient's vasculature in a percutaneous manner.By percutaneous it is meant that a location of the vasculature remotefrom the heart is accessed through the skin; typically using a surgicalcut down procedure or a minimally invasive procedure, such as usingneedle access through, for example, the Seldinger technique. The abilityto percutaneously access the remote vasculature is well-known anddescribed in the patent and medical literature. Depending on the pointof vascular access, the approach to the mitral valve may be antegradeand may rely on entry into the left atrium by crossing the inter-atrialseptum. Alternatively, approach to the mitral valve can be retrogradewhere the left ventricle is entered through the aortic valve. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners.

An example of a retrograde approach to the mitral valve is illustratedin FIGS. 7 and 8. The mitral valve MV may be accessed by an approachfrom the aortic arch AA, across the aortic valve AV, and into the leftventricle LV below the mitral valve MV. The aortic arch AA may beaccessed through a conventional femoral artery access route, as well asthrough more direct approaches via the brachial artery, axillary artery,radial artery, or carotid artery. Such access may be achieved with theuse of a guidewire 6. Once in place, a guide catheter 4 may be trackedover the guidewire 6. Alternatively, a surgical approach may be takenthrough an incision in the chest, preferably intercostally withoutremoving ribs, and placing a guide catheter through a puncture in theaorta itself. The guide catheter 4 affords subsequent access to permitplacement of the prosthetic valve device, as described in more detailherein.

In some specific instances, a retrograde arterial approach to the mitralvalve may be selected due to certain advantages. For example, use of theretrograde approach can eliminate the need for a trans-septal puncture(described below). The retrograde approach is also more commonly used bycardiologists and thus has the advantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 9. In this approach, access to the heart is gained viathoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access cannula is then placed through a puncture in thewall of the left ventricle at or near the apex of the heart and thensealed by a purse-string suture. The catheters and prosthetic devices ofthe invention may then be introduced into the left ventricle throughthis access cannula.

The trans-apical approach has the feature of providing a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalprocedure can be performed by surgeons who may not have the necessarytraining in interventional cardiology to perform the catheterizationsrequired in other percutaneous approaches.

Using a trans-septal approach, access is obtained via the inferior venacava IVC or superior vena cava SVC, through the right atrium RA, acrossthe inter-atrial septum IAS and into the left atrium LA above the mitralvalve MV.

As shown in FIG. 10A, a catheter 1 having a needle 2 may be advancedfrom the inferior vena cava IVC into the right atrium RA. Once thecatheter 1 reaches the anterior side of the inter-atrial septum IAS, theneedle 2 may be advanced so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. The catheter is then advanced into the left atrium over the needle.At this point, a guidewire may be exchanged for the needle 2 and thecatheter 1 withdrawn.

As shown in FIG. 10B, access through the inter-atrial septum IAS mayusually be maintained by the placement of a guide catheter 4, typicallyover a guidewire 6 which has been placed as described above. The guidecatheter 4 affords subsequent access to permit introduction of thedevice to repair the mitral valve, as described in more detail herein.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter may then be placed through this puncture orincision directly into the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous. For example, the antegrade approach maydecrease risks associated with crossing the aortic valve as inretrograde approaches. This can be particularly relevant to patientswith prosthetic aortic valves, which may not be crossed at all orwithout substantial risk of damage.

The prosthetic valve repair device may also be implanted usingconventional open-surgical approaches. For some patients, the devicesand methods of the invention may offer a therapy better suited for thetreatment of certain valve pathologies or more durable than existingtreatments such as annuloplasty or valve replacement.

The prosthetic valve repair device may be specifically designed for theapproach or interchangeable among approaches. A person of ordinary skillin the art can identify an appropriate approach for an individualpatient and design the treatment apparatus for the identified approachin accordance with embodiments described herein.

Orientation and steering of the prosthetic valve repair device can becombined with many known catheters, tools and devices. Such orientationmay be accomplished by gross steering of the device to the desiredlocation and then refined steering of the device components to achieve adesired result.

Gross steering may be accomplished by a number of methods. A steerableguidewire may be used to introduce a guide catheter and the prostheticvalve repair device into the proper position. The guide catheter may beintroduced, for example, using a surgical cut down or Seldinger accessto the femoral artery in the patient's groin. After placing a guidewire,the guide catheter may be introduced over the guidewire to the desiredposition. Alternatively, a shorter and differently shaped guide cathetercould be introduced through the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the mitral valve. For access via the trans-septal approach,the guide catheter may have a curved, angled or other suitable shape atits tip to orient the distal end toward the mitral valve from thelocation of the septal puncture through which the guide catheterextends. For the retrograde approach, as shown in FIGS. 7 and 8, guidecatheter 4 may have a pre-shaped J-tip which is configured so that itturns toward the mitral valve MV after it is placed over the aortic archAA and through the aortic valve AV. As shown in FIG. 7, the guidecatheter 4 may be configured to extend down into the left ventricle LVand to assume a J-shaped configuration so that the orientation of aninterventional tool or catheter is more closely aligned with the axis ofthe mitral valve MV. As shown in FIG. 8, the guide catheter mightalternatively be shaped in a manner suitable to advance behind theposterior leaflet. In either case, a pre-shaped guide catheter may beconfigured to be straightened for endovascular delivery by means of astylet or stiff guidewire which is passed through a lumen of the guidecatheter. The guide catheter might also have pull-wires or other meansto adjust its shape for more fine steering adjustment.

Selected Embodiments of Prosthetic Heart Valve Repair Devices andMethods

Embodiments of the present technology can be used to treat one or moreof the valves of the heart as described herein, and several embodimentsare well suited for treating the mitral valve. Introductory examples ofprosthetic heart valve repair devices, system components, and associatedmethods in accordance with embodiments of the present technology aredescribed in this section with reference to FIGS. 11A-22. It will beappreciated that specific elements, substructures, advantages, uses,and/or other features of the embodiments described with reference toFIGS. 11A-22 can be suitably interchanged, substituted or otherwiseconfigured with one another. Furthermore, suitable elements of theembodiments described with reference to FIGS. 11A-22 can be used asstand-alone and/or self-contained devices.

Systems, devices and methods in accordance with the present technologyprovide percutaneous implantation of prosthetic heart valve repairdevices in a heart of a patient. In some embodiments, methods anddevices treat valve diseases by minimally invasive implantation ofrepair devices behind one or more native leaflets in a subannularposition using the techniques described above with respect to FIGS.7-10B. In one embodiment, the repair device can be suitable for engagingan interior surface of a heart wall, such as a left ventricular wall,and a backside of a leaflet (e.g., the posterior leaflet of a mitralvalve in the heart of a patient). In another embodiment, the repairdevice can be suitable for implantation and repair of another valve inthe heart of the patient (e.g., a bicuspid or tricuspid valve).

FIG. 11A is a cross-sectional top view showing a prosthetic heart valverepair device 100 (“repair device 100”) in an expanded or extendedconfiguration in accordance with an embodiment of the presenttechnology, and FIGS. 11B and 11C are cross-sectional side views showingthe repair device 100 in the expanded configuration and a contracted ordelivery configuration, respectively. The repair device 100 can bemovable between the delivery configuration shown in FIG. 11C and theexpanded configuration shown in FIGS. 11A-B to be deployed under theposterior leaflet of the mitral valve. In the delivery configurationshown in FIG. 11C, the repair device 100 has a low profile suitable fordelivery through a lumen 102 of a small-diameter catheter 104 positionedin the heart via the trans-septal, retrograde, or trans-apicalapproaches described herein. In some embodiments, the deliveryconfiguration of the repair device 100 will preferably have an outerdiameter as small as possible, such as no larger than about 8-10 mm fortrans-septal approaches, about 6-8 mm for retrograde approaches, orabout 8-12 mm for trans-apical approaches to the mitral valve MV. Insome embodiments, the repair device 100 can be resilient and relativelyresistant to compression once deployed, making it easier to position andretain the device in the target location. As seen in FIG. 11A, repairdevice 100 may be preformed to assume a curved shape or othernon-straight shape when unconstrained in the deployed configuration.Accordingly, repair device 100 may be flexible and resilient so that itmay be formed in a more linear shape when positioned in lumen 102 ofcatheter 104 and it will resiliently return to its preformed deployedconfiguration when released from the catheter. Alternatively oradditionally, repair device 100 may be inflatable or fillable with afluid material as further described below, and it may be configured toassume a predetermined deployed shape as a result of fluid pressure.

In the embodiment shown in FIG. 11A, the repair device 100 includes asupport 110 for engaging and at least partially conforming to asubannular position between an interior surface of a heart chamber wall(e.g., a left ventricle wall) and a backside of a native valve leaflet(e.g., the mitral valve posterior leaflet). The support 110 cangenerally have a first end 112, a second end 114, and curved region 116between the first and second ends 112, 114. In one embodiment, thesupport 110 can be positioned as close as possible to the valve annulusin the subannular region (e.g., at the highest point in the spacebetween the outside-facing surface of the valve leaflet and theventricular wall). The curved shape of the curved region 116 mayaccommodate and/or otherwise conform to the curved shape of theposterior mitral annulus, or it may be relatively stiff to encourage aspecific shape. The length of the support 110 can extend substantiallythe entire distance between the commissures, or only part way around theposterior leaflet PL without reaching the commissures, or beyond one orboth commissures so as to extend below a portion of the anterior leafletAL. The support 110 is preferably configured to be wedged or retained bycompression or friction with the underside (e.g., the outward-facingsurface or downstream side) of the posterior leaflet PL and the innerwall of the ventricle, and/or engagement with the chordae tendineaeattached to the posterior leaflet PL. In some embodiments the support110 is configured to be positioned between the basal and/or tertiarychordae tendineae and the ventricular wall. The support 110 willpreferably be sufficiently rigid to deflect the posterior leaflet PL tothe desired post-treatment configuration, but still having someflexibility to allow it to flex and avoid tissue damage under highforces. The support 110 may also have some resilience andcompressibility to remain engaged with the chordae tendineae, theleaflet and the wall tissue as the heart changes shape both acutely andlong-term. The support can be a frame, bladder, balloon, foam, tube(e.g., a mesh tube), or other structure that is configured to extend(e.g., expand) at a target site in a manner that pushes or otherwiserepositions a leaflet of a native valve from a pre-treatment position inwhich the native leaflets fail to coapt properly to a post-treatmentposition in which the leaflets coapt during a portion of the cardiaccycle. The support can be further configured to brace, support, orotherwise maintain the leaflet in the post-treatment position for atleast a portion of the cardiac cycle, preferably permanently.

The support 110 can be pre-shaped such that upon deployment, the repairdevice 100 accommodates (e.g., approximates) the shape of the nativeanatomy or the desired post-treatment shape of the native anatomy. Forexample, the support 110 can be pre-shaped to expand into a “C” shape orother suitably curved shape to accommodate the curvature of the mitralvalve annulus and/or to conform to a portion of the native mitral valveannulus. In some embodiments, several components of the support 110 canhave a subannular engaging surface 118 that includes one or more peaks(not shown) and one or more valleys (not shown) in theupstream-downstream direction for accommodating or conforming to thenative saddle-shape contour of the mitral annulus. An outer edge 117 ofthe curved region 116 of the support 110 can be positionable against theinterior surface of the heart wall.

Referring to FIGS. 11A and 11B together, the support 110 can include acentral spine 111 (e.g., a beam, a tube, or a frame) that may be a stentstructure, such as a balloon-expandable or self-expanding stent. Inother embodiments, the spine 111 can be a coiled spring, a braided tube,a wire, a polymeric member, or other form. The spine 111 and/or otherportions of the support 110, in various embodiments, can include metalmaterial such as nickel-titanium alloys (e.g. nitinol), stainless steel,or alloys of cobalt-chrome. In other embodiments, the support 110 caninclude a polymer such as Dacron®, polyester, polypropylene, nylon,Teflon®, PTFE, ePTFE, etc. Other suitable materials known in the art ofelastic and/or expandable or flexible implants may be also be used toform some components of the support 110. As shown in FIG. 11A, severalembodiments of the spine 111 can be formed, at least in part, from acylindrical braid or stent structure comprising elastic filaments.Accordingly, the spine 111 and/or other portions of the support 110 caninclude an elastic, superelastic or other shape memory component thatself-expands upon deployment of the device 100 to a formed or apre-formed configuration at a target site. The spine 111 can furtherinclude a lumen 119 through which a guidewire (not shown) and/orstrengthening/stiffening elements 115 (shown in FIG. 11B), such aswires, coils, or polymeric elements, can be placed into or integratedwithin the support 110. Such strengthening/stiffening elements 115 canbe inserted into the lumen 119 before or during deployment of the repairdevice 100 to provide additional resistive pressure against the cardiactissue once implanted. Spine 111 can be flexible and resilient so it canbe straightened for delivery in a catheter or sheath or over a wire, andit can resiliently return to a curved shape (e.g., a curved shapesimilar to the native valve annulus) when unconstrained. In someembodiments, the spine 111 preferably has sufficient stiffness tostructurally support the treated valve leaflet in the desired positionand shape. In some embodiments, spine 111 may be covered with abiocompatible, flexible fabric or polymer, preferably one that allowstissue ingrowth.

The support 110 can further include an extension unit 120 attached toand/or positioned around at least a portion of the spine 111. In oneembodiment, for example, the extension unit 120 can be biocompatiblewith cardiac tissue at or near the native valve of the patient so as topromote tissue ingrowth and strengthen implantation of the repair device100 within the native valve region. In exemplary embodiments, extensionunit 120 can comprise a flexible cover of biocompatible fabric orpolymer that surrounds spine 111. In one embodiment, the extension unit120 can include an expandable member, such as an expandable tube,balloon, bladder, foam or other expandable material, that is coupled tothe spine 111. The expandable member may itself surround spine 111, maybe held within a flexible fabric or polymeric cover extending around orattached to spine 111, or may be attached directly to a lateral side ofspine 111. For example, the extension unit 120 can be an elastic orinelastic balloon made from impermeable, flexible biocompatiblematerials. The extension unit 120 can comprise a fabric or otherflexible, stretchable and/or biocompatible material such as braided,woven, or crocheted Dacron®, expanded PTFE (Gore-Tex®), bovinepericardium, or other suitable flexible material to integrate withadjacent tissue and promote tissue ingrowth to facilitate furtherstability of the repair device 100 in the subannular position. In otherembodiments, the extension unit 120 can include polyester fabric, apolymer, thermoplastic polymer, a synthetic fiber, a natural fiber orpolyethylene terephthalate (PET). Several embodiments of the extensionunit 120 may be pre-shaped to accommodate a relatively fixed maximaldimension and shape when the repair device 100 is implanted. In variousembodiments, the extension unit 120 can be porous and/or adhere to theinterior surface of the heart wall and/or the backside of the leaflet.Tissue ingrowth into the extension unit 120 can form a pannus of tissuewhich is hemocompatible and can strengthen the combined structure of therepair device 100, the subannular tissue and/or interior surface of theheart wall, and the backside of the leaflet. Extension unit 120 will beexpandable (e.g., in a transverse or radial direction relative to thelongitudinal axis of the spine 111) from a collapsed configuration forendovascular or trans-apical delivery to an expanded configurationsuitable for bracing the valve leaflet in the desired position.Extension unit 120 will usually be more flexible than spine 111 when inan unexpanded configuration, and in some embodiments will becomesubstantially more rigid when expanded, e.g. by filling or inflatingwith a fluid. This rigidity may be imparted solely by fluid pressure, orby hardening or curing the fluid (e.g. epoxy or cement) within theextension unit.

The support 110 can further include a plurality of projections 130 anddepressions 131 in the expanded configuration. The projections 130alternate with depressions 131 such that each depression is disposedbetween two projections, forming a series of peaks and valleys. Forexample, the projections 130 can be features of the extension unit 120that extend toward the other native leaflet and generally parallel tothe underside of the supported leaflet such that the projections 130extend between and engage the secondary and/or tertiary chordaetendineae that tether the leaflet (e.g., the mitral valve posteriorleaflet) to the ventricular wall. In some embodiments all or a portionof the projections 130 may extend in generally the same (anterior)direction, while in other embodiments the projections 130 may extend ina radially inward direction relative to the curvature of the spine 111(or native valve annulus). As such, a portion of the secondary and/ortertiary chordae tendineae can be positioned in the depressions 131after the repair device 100 has been deployed. The upper orleaflet-facing sides of the projections 130 are preferably smooth andwide enough to support the leaflet without abrading or damaging theleaflet should it move or rub against the projections during the cardiaccycle. The depressions 131 are preferably wide enough to receive atleast one of the chordae somewhat snugly to inhibit lateral movement ofthe support.

Referring still to FIGS. 11A-B and in accordance with an embodiment ofthe present technology, the extension unit 120 can include a pluralityof pockets 132 that can be configured to receive filler material 140during or upon deployment of the device 100 to form the projections 130.For example, a liquid that cures into a permanently semi-flexible orrigid material can be injected into the extension unit 120 to at leastpartially fill the pockets 132 of the extension unit 120 and therebyform the projections 130. In other embodiments, not shown, the pockets132 can be expanded to form the projections 130 using internal elementssuch as segmented stents, one or more coiled spring elements, or otherreinforcement structures. For example, the stent or spring might bepre-shaped to help the device 100 assume the deployed configuration(e.g., shape and profile). Accordingly, once in the deployedconfiguration, the projections 130 can be interspersed between thechordae tendineae CT.

The side of the support opposite the projections 130 (i.e., posteriorside in mitral embodiments) will preferably be configured toatraumatically and compressively engage the ventricular wall to assistin anchoring the device in place. The posterior surface may be a soft,compressive, and resilient material, preferably atraumatic to the heartwall, and preferably one that encourages tissue in-growth. In someembodiments, the posterior side may have retention elements, e.g.spikes, hooks, bristles, points, bumps, or ribs, protruding from itssurface, to engage the ventricular wall to further assist in anchoringand immobilizing the device. The posterior side may also have one ormore expandable, resilient, or spring-like elements thereon that engagethe ventricular wall and urge the support 110 in the anterior direction(away from the wall) to firmly and compressively engage the chordaetendonae between the projections 130. This can supplement or substitutefor the expansion of the support 110 or extension member.

FIGS. 12A and 12 B are cross-sectional top views of the repair device100 and a delivery system at stages of implanting the repair device 100(spine 111 removed for clarity in FIG. 12A) in accordance with anembodiment of the present technology. Referring to FIG. 12A, a guidewireGW is positioned at the implant site and a guide catheter 1210 is passedover the guidewire GW until the guide catheter 1210 is positioned atleast proximate the valve. An optional delivery catheter or sheath 1220can then be passed through the guide catheter 1210. The guidewire GW canbe withdrawn, and the repair device 100 is then passed through the guidecatheter 1210 or the optional sheath 1220. In another embodiment, theguidewire GW is received in the lumen 119 (FIGS. 11A and 11B) of therepair device 100 such that the repair device 100 passes over theguidewire GW during implantation. When the repair device 100 is used torepair a native mitral valve MV, the guidewire GW can be positionedunder the posterior leaflet PL of the native mitral valve MV, the guidecatheter 1210 and/or optional sheath 1220 are then placed at a targetsite under the posterior leaflet PL, and then the repair device 100 ispositioned within the guide catheter 1210 and/or the optional sheath1220 at the target site. At this stage, the anterior and posteriorleaflets fail to coapt, resulting in a gap G between the posteriorleaflet PL and the anterior leaflet AL.

FIG. 12B shows a subsequent stage of implanting the repair device 100under the posterior leaflet PL of the native mitral valve MV. The sheath1220 can have a lumen 1222, and the repair device 100 can be attached toa shaft 1230 by a release mechanism 1232. Additionally, an inflationtube 1240 can extend along or through the sheath 1220 and through aone-way valve (not shown) into the extension unit 120 of the support110. In one embodiment, the repair device 100 is contained in a radiallycollapsed state in the lumen 1222 of the sheath 1220 as the repairdevice 100 is positioned under the posterior leaflet PL, and then thesheath 1220 is retracted proximally to expose the repair device 100 atthe target site. After the repair device 100 has been exposed, thefiller material 140 is injected into the extension unit 120 via theinflation tube 1240 causing the projections 130 to extend away from thespine 111 towards the central axis of the valve orifice (arrows AD). Theprojections 130 accordingly push at least the free edge of the posteriorleaflet PL toward the anterior leaflet AL until the gap G (FIG. 12A) atleast partially closes to enhance the competency of the native mitralvalve MV. In the embodiment shown in FIG. 12B, the gap G is completelyeliminated such that the free edge of the posterior leaflet PL fullycoapts with the free edge of the anterior leaflet AL. Additionally, thechordae tendineae CT positioned in the depressions 131 between theprojections 130 secure the repair device 100 in the subannular space.The release mechanism 1232 is then activated to separate the repairdevice 100 from the shaft 1230. The sheath 1220 along with the shaft1230 and inflation tube 1240 are then withdrawn from the patient.

In other embodiments, the repair device 100 may include a fluidabsorbing material that expands after implantation by absorption ofblood or other fluids to inflate the extension unit 120 either inaddition to or in lieu of using the inflation tube 1240. For example,the extension unit 120 may have a fluid permeable cover and an absorbentmaterial within the cover that expands as it absorbs fluid, or theextension unit 120 can be a foam that expands to form the projections130. Alternatively, the extension unit 120 may be filled with a fluidabsorbing substance such as a biocompatible hydrogel which expands whenexposed to blood or other fluid. In this way, the support 110 may beimplanted and optionally expanded partially, then allowed to expand toits fully expanded configuration by absorption of fluids. Alternatively,the extension unit 120 may be sufficiently porous to allow blood to passinto it such that blood will collect and fill up the extension unit.Eventually, the blood may clot and be replaced by tissue to strengthenand rigidify the repair device 100. In further embodiments, theextension unit 120 may be configured to receive an injectable materialto realize a fully-expanded configuration.

FIG. 13 is a cross-sectional view schematically illustrating a leftatrium, left ventricle, and native mitral valve of a heart with anembodiment of the repair device 100 implanted in the native mitral valveregion. In this embodiment, the repair device 100 is implanted in asubannular position and behind the posterior leaflet PL of the nativemitral valve MV at the ventricular side of the mitral annulus AN asdescribed above with reference to FIGS. 12A and 12B. The repair device100, for example, can have a ventricular wall engaging surface 150 thatengages the ventricular wall along a distance DV and a posterior leafletengaging surface 160 configured to engage the outward-facing surface(e.g., underside or downstream side) of the posterior leaflet PL. Therepair device 100 is retained in this subannular position by the chordaetendineae CT (e.g., the basal or tertiary chordae tendineae which areassociated with the posterior leaflet PL closest to the annulus AN). Asrepair device 100 is expanded from a collapsed, delivery configurationto an expanded, deployed configuration, the width or area of theposterior leaflet engaging surface 160 enlarges. In some embodiments,repair device 100 can be expanded until the posterior leaflet engagingsurface has the desired width or area, e.g., until the posterior leafletis repositioned and/or reshaped such that it coapts with the anteriorleaflet and regurgitation through the valve is reduced or eliminated. Asshown in FIG. 13, when the device 100 is in the deployed configuration,the posterior leaflet engaging surface 160 engages the outward-facingsurface (e.g., underside) of at least the posterior leaflet PL along adistance DL from the posterior wall of the ventricle toward the anteriorleaflet AL to push, brace or otherwise support the posterior leaflet PLsuch that it coapts with the anterior leaflet AL and/or otherwisereduces mitral valve regurgitation (e.g., drives the posterior leafletPL toward the anterior leaflet AL into at least a partially closedposition). The distance DL can be selected or controlled to adapt therepair device 100 to the specific anatomy of the patient. In severalembodiments, the distance DL is from about 2-20 mm, preferably at leastabout 8 mm, or in other embodiments from about 8 to about 12 mm. In someembodiments, the device 100 can support the posterior leaflet PL in afully closed position, and in further embodiments the repair device 100can extend the posterior leaflet PL toward the anterior leaflet to aclosed position that extends beyond the leaflet's naturally closedposition. For example, the shape of the posterior leaflet PL may bechanged by expanding the repair device 100 to push it toward or bracingit in a position closer to the anterior leaflet AL. In one example, therepair device 100 can have a triangular or polygonal cross-section forengaging the ventricular wall, the annulus AN, and the outward-facingsurface of the posterior leaflet PL. In other embodiments, the repairdevice 100 can have a circular, oval, elliptical, or oblongcross-section.

The overall cross-sectional shape of the repair device 100 can determinethe resting location of the posterior leaflet PL as it is braced in theat least partially closed position. Therefore, the distances DV and DL,and the curvatures of the ventricular wall engaging surface 150 and theposterior leaflet engaging surface 160, can be configured to accommodatedifferent anatomical requirements of different patients. For example,FIG. 14 shows another embodiment of a repair device 100 a similar to therepair device 100 illustrated in FIG. 13, but in the deployedconfiguration the repair device 100 a includes a ventricular wallengaging surface 150 a with a vertical or cranial-caudal distance DVathat is less than the corresponding distance DV of the ventricular wallengaging surface 150 of the repair device 100 shown in FIG. 13. Therepair device 100 a further includes a posterior leaflet engagingsurface 160 a that contacts the underside of the posterior leaflet PLalong posterior-anterior dimension by a distance DLa greater than thatof the posterior engaging surface 160 of the repair device 100 of FIG.13. As such, the repair device 100 a is able to support the posteriorleaflet PL in a position closer to the anterior leaflet AL than thedevice 100; the repair device 100, more specifically, can move the linealong which posterior leaflet PL hinges to open and close away from theposterior heart wall of the left ventricle and closer to the anteriorleaflet AL to reduce the size of the movable portion of the posteriorleaflet that opens and closes during the cardiac cycle. The leaflethinge may alternatively be eliminated altogether so that the leaflet issubstantially stationary throughout the cardiac cycle.

FIG. 15 is a cross-sectional side view of a repair device 100 b inaccordance with another embodiment of the present technology. The repairdevice 100 b shown in FIG. 15 is similar to the repair device 100 ashown in FIG. 14, but the repair device 100 b in the deployedconfiguration is flatter (shorter in the atrial-ventricular direction)than the repair device 100 a. For example, the repair device 100 b has aventricular wall engaging surface 150 b that engages the ventricularwall along a distance DVb that is less than the distance DVa of therepair device 100 a. The repair device 100 b may be easier to implantthan the repair device 100 a because the lower profile of the repairdevice 100 b can fit in a smaller delivery catheter and in the tightspaces between the ventricular heart wall and the chordae tendineae CT.

FIGS. 16A and 16B are cross-sectional side views of a repair device 100c in accordance with another embodiment of the present technology. Inthis embodiment, the repair device 100 c has an extension unit 1620including a bellows 1622 that preferentially expands in the anteriordirection AD. The bellows 1622 can be an accordion style portion of theextension unit 1620, and the remainder of the extension unit 1620 can bea flexible fabric or polymeric material that is made from the samematerial as the bellows 1622 or a different material. In otherembodiments, the portion of the extension unit 1620 other than thebellows 1622 can be made from a metal or other material that can flex ata lower bend 1624. In operation, as the extension unit 1620 is inflated,the bellows 1622 allows the projection 130 to move in the anteriordirection AD such that the repair device 100 c engages the underside ofthe posterior leaflet PL by an increasing distance (e.g., DLc1 in FIG.16A to DLc2 in FIG. 16B).

FIGS. 17A-17C are schematic top views of a native mitral valve MV in theheart viewed from the left atrium and showing an embodiment of any ofthe repair devices 100-100 c described above implanted at the nativemitral valve MV in accordance with additional embodiments of the presenttechnology (repair devices 100-100 c are identified collectively as“repair device 100” and shown in dotted lines with respect to FIGS.17A-17C). The presence of the projections 130 may allow the repairdevice 100 to expand fully for supporting or bracing the outward-facingsurface of the posterior leaflet PL in at least a partially closedposition without tearing or excessively displacing or stretching thechordae tendineae which retain the repair device 100 at the targetimplantation location. In some embodiments, the chordae tendineae alsohelp retain the repair device 100 in a desired cross-sectional shape.The projections 130 may be configured to extend anteriorly or radiallyalong the underside of posterior leaflet PL through gaps between thebasal or tertiary chordae by a sufficient distance to brace theposterior leaflet PL in the desired position for effective coaptation.The distal tips of the projections 130 are preferably rounded and smoothto avoid trauma to the leaflet and to allow the leaflet to bend or foldaround the projections 130 in the partially closed position. Theprojections 130 may also have structures, materials, or coatings thereonto engage and retain the chordae tendineae such that the projections 130will not pull out in the reverse direction. For example, the projections130 may have an enlarged head or T-shape at their distal ends, scales orbackward-pointing tines along their sidewalls, or other features thatallow the projections 130 to slide easily between the chordae tendineaein one direction but to resist movement in the other. The projections130 may also be coated with a tissue in-growth promoting agent. In someembodiments, the device 100 can include other materials that encouragestissue ingrowth and/or tissue healing around the device such that thedepressions 131 between the projections 130 may be filled with tissue(e.g., pannus of tissue) leaving a relatively smooth surface exposed tothe left ventricle.

As shown in FIG. 17A, the repair device 100 can have a relativelyconsistent cross-sectional dimension over the length of the device(e.g., at the first and second ends 112, 114 and along the curved region116). In a different embodiment shown in FIG. 17B, the curved region 116device 100 can have a cross-sectional dimension D1 that is larger thancross-sectional dimensions D2, D3 at the first and second ends 112, 114,respectively. In this embodiment, the larger cross-sectional dimensionD1 may assist the coaptation of the posterior leaflet PL with theanterior leaflet AL in the central region CR of the native mitral valveMV. In other embodiments, the device 100 can be configured to havelarger cross-sectional dimensions at one or more ends (e.g., firstand/or second ends 112, 114). For example, FIG. 17C shows a repairdevice 100 having an asymmetric cross-section profile. As shown in FIG.17C, the repair device can have a second end 114 having across-sectional dimension D4 that is larger than cross-sectionaldimensions D5 and D6 of the curved region 116 and the first end 112,respectively. Accordingly, the repair device 100 can include a varietyof dimensions (e.g., cross-sectional dimensions) and shapes that can beused to address a specific heart valve morphology of a patient. Forexample, the device 100 could be shaped and sized to repair areas ofregurgitation within the native valve while preserving functionality ofthe leaflets (e.g., posterior leaflet function) to the extent possiblein healthy areas of the native valve. In alternative embodiments, thedevice 100 may have a plurality of expandable, inflatable, or fillableregions or pockets arranged along the length of the device which can beindependently expanded by injection of fluid to create regions ofdifferent cross-sectional size or shape along the length of device 100.In some embodiments, each of these regions or pockets could beselectively expanded as the heart continues to beat until the posteriorleaflet is positioned and shaped as needed to reduce or eliminateregurgitation through the valve.

Repair devices in accordance with any of the foregoing embodiments canhave other shapes, dimensions, sizes and configurations to addresspatient specific anatomy or to otherwise achieve coaptation of thenative valve leaflets in a specific patient. The shape and dimension ofthe repair device 100 may be selected such that the posterior leaflet isbraced in a position which results in sealing coaptation of theposterior and anterior leaflets during systole. The repair device 100may be adjustable in size or shape before or after placement to allowthe physician to adjust the device to achieve the desired post-treatmentleaflet position. For example, the repair device 100 may have malleableportions that can be manually shaped by the physician, mechanicallyarticulating portions that can be remotely adjusted, or inflatableportions into which a fluid may be injected to change their shape orsize.

One aspect of several embodiments of the repair devices 100-100 cdescribed above is that the support 110 is secured at the target sitewithout anchors or other components that pierce the tissue of theleaflets, annulus and/or the wall of the heart. For example, thecombination of expanding or otherwise extending the projections 130between the chordae tendineae and pressing the support 110 against theunderside of the posterior leaflet and the wall of the left ventriclesecurely holds the repair device in place. This is expected to simplifythe treatment and reduce trauma to the heart.

In other embodiments, repair device 100 may have features on itsexterior to enhance fixation with the native tissue. For example, theposterior surface that engages the wall of the ventricle, and/or theupper surface that engages the posterior leaflet, may have barbs, bumps,ribs, spikes, or other projections configured to engage the tissue andenhance fixation through friction or by penetration of the tissuesurface. Additionally or alternatively, friction-enhancing fabrics,polymers or other materials may be provided on these surfaces. In otherembodiments, loops or hooks may be coupled to repair device 100 whichare configured to engage with or extend around the chordae or papillarymuscles. Further, the material used to cover repair device 100 mayenhance tissue ingrowth such that the device is encapsulated in tissuewithin a short time after implantation.

Another aspect of several embodiments of the repair devices 100-100 c isthat the degree to which the projections 130 of the extension unit 120extend in an anterior direction can be controlled to custom tailor therepair device 100 to the anatomy of a specific patient. For example,when the extension unit 120 is an inflatable bladder or balloon, thedistance that the projections 130 extend in the anterior direction canbe controlled by the amount of filler material 140 that is injected intothe extension unit 120. This is expected to provide enhanced flexibilityand customization of the repair device 100.

FIG. 18 is a perspective view of another embodiment of a repair device1800 having a curved support 1810 with a first end 1812 and a second end1814. The support 1810 may be similar to or the same as any of thesupports 110 described above. The repair device 1800 further includesretention elements 1890 projecting from the support 1810 to enhanceanchoring to the native tissue. Each retention member can have a post1892 configured to extend through the opening between the valve leafletsand a cross-member 1894 configured rest on a upstream side or exteriorsurface of the valve leaflets. The retention elements 1890 may have aT-shape as shown in FIG. 18, lollipop shape, arrowhead shape, or othersuitable structure to resist passing back between the leaflets.Optionally, the retention elements 1890 may be configured to pressagainst, frictionally engage with, or penetrate the tissue of the nativeannulus, posterior leaflet, or atrial wall. In still other embodiments,the retention elements 1890 may be configured to engage and optionallypenetrate into the ventricular wall. For example, a ventricularwall-engaging surface of the repair device may have one or moreretention members in the form of spikes, barbs, ridges, bumps, hooks, orother frictional or wall-penetrating structures disposed thereon. Suchretention members can be delivered through a central lumen of the repairdevice 1800 after placement, or be automatically deployed as the repairdevice 1800 expands.

FIG. 19 is a side cross-sectional view of the repair device 1800 afterthe repair device has been implanted under the posterior leaflet PL of anative mitral valve MV. In this embodiment, the retention elements 1890extend from the support 1810 between the leaflets to an upstream orsuper-annular side of the leaflets. Preferably, the retention elements1890 are mounted near the ends 1812, 1814 of the support 1810 so as toextend through the commissures of the valve to the upstream side (shownin more detail in FIG. 20C below). Alternatively, the retention elements1890 can penetrate through the leaflet itself (shown in more detail inFIG. 19).

FIG. 20A is a schematic top view of a native mitral valve MV in theheart viewed from the left atrium and showing normal closure of a nativeposterior leaflet (PL) and a native anterior leaflet (AL), and FIG. 20Bis a schematic top view of a native mitral valve MV in the heart viewedfrom the left atrium and showing abnormal closure of the posterior andanterior leaflets PL, AL. In FIG. 20B, the posterior leaflet PL fails tosufficiently coapt with the anterior leaflet AL, which in turn allowsblood to regurgitate through the valve. FIG. 20C is a schematic top viewshowing an embodiment of the repair device 1800 (shown in dotted lines)implanted at a subannular location of the otherwise abnormally closednative mitral valve MV of FIG. 20B in accordance with an embodiment ofthe present technology. As shown in FIG. 20C, after the repair device1800 is deployed behind the posterior leaflet PL in the subannularposition, the repair device 1800 braces the posterior leaflet PL fromthe backside surface of the leaflet to support the leaflet in at least apartially closed position in which it sufficiently coapts with theanterior leaflet AL to reduce or eliminate regurgitation. The posteriorleaflet PL in this example is braced such that it remains in asubstantially closed position and is substantially prevented from movingaway from the anterior leaflet AL during the cardiac cycle. The anteriorleaflet AL can continue to open and close during diastole and systole,respectively. The repair device 1800 includes one or more retentionelements 1890 as described above with respect to FIGS. 18 and 19. Forexample, the retention elements 1890 are shown extending through thecommissures of the valve to the upstream side.

Various aspects of the present technology provide heart valve repairdevices that can reduce the effective annular area of the mitral valveorifice, by holding the posterior leaflet permanently closed, or inother embodiments mostly closed, or in further embodiments in anextended position beyond its natural closed position state. When therepair device is deployed at the target region of the mitral valve, thenative valve may have only a functional anterior leaflet, therebyreducing the effective orifice area. Not to be bound by theory, theremaining effective orifice area is believed to be sufficient to avoid aphysiologically detrimental or an excessive pressure gradient throughthe mitral orifice during systole. Regurgitant mitral valves typicallyhave dilated to a size much larger than their original area, so areduction in the orifice area may not compromise the valve.Additionally, many conventional mitral valve repair surgeries result ina posterior leaflet that extends only a very short distance from theposterior annulus. After these surgeries, the motion of the anteriorleaflet provides nearly all of the orifice area. Accordingly,immobilization of the posterior leaflet of a dilated mitral valve in theclosed position is not believed to lead to hemodynamic complications dueto a high pressure gradient during antegrade flow through the valve.

Following implantation and deployment of the repair device in the targetlocation, and while the device extends and holds the posterior leafletof the mitral valve at least partially in the closed position, thedevice additionally can apply tension from the valve leaflet to thechordae tendineae attached to the papillary muscles and the ventricularwall. This additional tension applied by the implanted repair devicecan, in some embodiments, pull the papillary muscles and the free wallof the left ventricle closer to the mitral valve to reduce the tetheringeffect on the anterior leaflet and allow the anterior leaflet to closemore effectively. Thus, in addition to the hemodynamic benefit of acompetent mitral valve by at least partially closing the posteriorleaflet, the device might slightly improve morphology of both theanterior leaflet and the left ventricle, and help the valve to provide astructural benefit to the ventricle.

In another aspect of the present technology, several embodiments of therepair device 100 can be used in conjunction with a prosthetic heartvalve replacement device delivered percutaneously or trans-apically totreat an abnormal or diseased native heart valve. Percutaneous ortransapical replacement of the mitral valve is particularly challengingdue, at least in part, to the non-circular, large, and asymmetric shapeof the mitral annulus. In addition, a diseased mitral valve can enlargeover time making implantation of a percutaneous prosthetic heart valveeven more challenging. In accordance with an embodiment of the presenttechnology, the repair device 100 can be configured to change either anannulus shape or an annulus cross-sectional dimension when the device100 is in the deployed configuration. In a particular example, therepair device 100 can be implanted in the sub annular position behind aposterior leaflet PL of a native mitral valve MV to decrease theeffective size of the mitral valve annulus. In another embodiment, therepair device 100 can be configured to change the native annulus shapeto a more circular shape or having a circular orifice, which may beadvantageous for receiving some variations of implantable prostheticheart valves. In one embodiment, the repair device 100 may be implantedin a first surgical step and implantation of a prosthetic heart valvedevice may occur at a second surgical step either immediately or at somefuture date.

FIG. 21A is a schematic top view of a native mitral valve MV in theheart viewed from the left atrium and showing a heart valve repairdevice 100 (shown in dotted lines) implanted at the native mitral valvewherein the opposing ends 112, 114 of the repair device 100 extendbeyond the native valve commissures of the posterior leaflet PL. In thisembodiment the first and second ends 112, 114 can support at least aportion of the anterior leaflet AL and/or create a smaller and/orcircular native mitral valve orifice 170 for receiving a replacementheart valve device. FIG. 21B illustrates another embodiment of a heartvalve repair device 100 (shown in dotted lines) implanted at the nativemitral valve MV, wherein the repair device 100 has first and second ends112, 114 that extend beyond the native valve commissures and meet,overlap and/or join behind the anterior leaflet AL. Additionalstrengthening and/or stiffening materials (e.g., nitinol, stainlesssteel, etc.) can be used, in some embodiments, to hold the ends 112, 114in desired locations behind the anterior leaflet AL. In the embodimentshown in FIG. 21B, the device 100 can either partially or fully supportthe subannular region behind the anterior leaflet AL as well aspartially or fully support the anterior leaflet AL to effectively shrinkthe effective annular area and/or create a smaller and/or more circularnative mitral valve orifice 170 for receiving a replacement heart valvedevice.

In one example, the smaller and/or circular native mitral valve orifice170 may be able to accommodate valve prostheses designed forimplantation in circular orifices, such as aortic valve replacementdevices. For example, FIG. 21C is a schematic top view of the nativemitral valve MV shown in FIG. 21A and showing the heart valve repairdevice 100 (shown in dotted lines) and a prosthetic heart valve 180implanted at the native mitral valve MV.

As described above with respect to FIGS. 7-10B, a variety ofpercutaneous and minimally invasive techniques can be used to access andimplant the heart valve repair devices disclosed herein. In one specificembodiment, and in accordance with an embodiment of the presenttechnology, FIG. 22 illustrates a method 2200 for repairing a nativevalve of a patient. The method 2200 can include positioning a heartvalve repair device in a subannular position and behind at least oneleaflet, wherein the leaflet is connected to chordae tendineae (block2202). The repair device can have a support in a contractedconfiguration. Optionally, the support can include an extension unitconfigured to be biocompatible with cardiac tissue at or near the nativevalve of the patient. The method 2200 can also include extending thesupport in the subannular position such that the support engages aninterior surface of a heart wall and a backside of the at least oneleaflet (block 2204). Further optional steps of the method 2200 caninclude injecting a filler material into the extension unit (block2206).

In one embodiment, positioning of a heart valve repair device caninclude placing a percutaneously positioned guide catheter with itsdistal tip approaching one of the mitral valve commissures andpositioned at the end of the groove behind the posterior leaflet. Asteerable guidewire and flexible catheter can then be advanced from theguide catheter around the groove behind the posterior leaflet and in thedirection of the other opposite commissure. Once the catheter is inplace, the guidewire can be withdrawn and the repair device can beintroduced (e.g., in a contracted configuration) through the flexiblecatheter. If necessary, a flexible secondary guiding catheter or sheathcan be placed over the guidewire or catheter before introducing therepair device. The repair device can be contained in the contractedconfiguration by a thin extension unit or sheath during the introductionprocess. Once the repair device is positioned behind the posteriorleaflet, the sheath is withdrawn and the device is deployed or inflated.Further guidance can be used to ensure that the projections, if present,expand between the tertiary chordae tendineae. In some embodiments,radiopaque markers can be incorporated in known locations on thecatheter, the sheath, or the repair device to ensure proper delivery tothe target location.

The repair devices, systems and methods disclosed herein may also beused to repair and/or treat regurgitant tricuspid valves. The tricuspidvalve, like the mitral valve, has leaflets tethered by chordaetendineae. Such a repair device as disclosed herein might be deployedbehind one, two or all three of the tricuspid valve leaflets.

In still further applications, embodiments of the repair devices inaccordance with the present technology can be used to enhance thefunctionality of various prosthetic valves. For example, the repairdevice can be configured to push or brace prosthetic leaflets orprosthetic aptation devices implanted at a native heart valve therebyfacilitating coaptation of the prosthetic leaflets. In particularexamples, several embodiments of repair devices in accordance with thepresent technology can be used to at least partially coapt (a) theprosthetic aptation devices shown and described in U.S. Pat. No.7,404,824 B1, filed by Webler et al. on Nov. 12, 2003, which is hereinincorporated by reference or (b) the prosthetic leaflets of devicesshown and described in U.S. Pat. No. 6,730,118, filed by Spenser et al.on Oct. 11, 2002 and/or U.S. Patent Publication No. 2008/0243245, filedby Thambar et al. on May 28, 2008, which is also incorporated herein byreference. In another embodiment, several embodiments of repair devicesin accordance with the present technology can also be used concomitantlywith other valve therapies, such as the MitraClip® device sold by AbbottLaboratories, which connects the free edges of the two leaflets of themitral valve.

Various aspects of the present disclosure provide heart valve repairdevices, systems and methods for bracing at least a portion of theposterior leaflet of the native mitral valve in a closed or partiallyclosed position to reduce or eliminate regurgitation occurrence in themitral valve, while retaining enough effective valve area to prevent anysignificant pressure gradient across the mitral valve. Other aspects ofthe present disclosure provide heart valve repair devices, systems andmethods for reducing the effective area of the mitral orifice and/orrendering a mitral valve competent without substantially reshaping thenative annulus. Additionally, while additional tethering or anchoringmechanisms known in the art can be used to anchor the device in thetarget location, the devices described herein do not require additionaltethering or anchoring mechanisms.

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.The embodiments, features, systems, devices, materials, methods andtechniques described herein may, in certain embodiments, be applied toor used in connection with any one or more of the embodiments, features,systems, devices, materials, methods and techniques disclosed in U.S.Provisional Patent Application No. 61/825,491, which is incorporatedherein by reference in its entirety.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

The following clauses illustrate example subject matter describedherein.

Clause 1. A mitral valve repair device, comprising: a frame comprising ashape memory material; and an extension unit positioned around at leasta portion of the frame, the extension unit comprising a flexiblematerial configured to move from a contracted configuration for deliveryto an expanded configuration, the extension unit having an inner volumeconfigured to be filled with blood in the expanded configuration, andthe extension unit configured to extend inwardly toward a central axisof an orifice of a native mitral valve to close a gap relative to a freeedge of an anterior leaflet of the native mitral valve in the expandedconfiguration.

Clause 2. The mitral valve repair device of clause 1, wherein theflexible material comprises a cover, and wherein the cover is configuredto enable tissue ingrowth.

Clause 3. The mitral valve repair device of clause 1 or 2, wherein, whenin the contracted configuration, the frame and the extension unit aresized to fit within a delivery catheter.

Clause 4. The mitral valve repair device of any one of clauses 1 through3, wherein the extension unit comprises a fluid absorbing materialwithin the inner volume.

Clause 5. The mitral valve repair device clause 4, wherein the fluidabsorbing material comprises a foam.

Clause 6. The mitral valve repair device clause 4, wherein the fluidabsorbing material comprises a hydrogel.

Clause 7. The mitral valve repair device of any one of clauses 4 through6, wherein, when in contact with the blood, the fluid absorbing materialis configured to expand to inflate the extension unit from thecontracted configuration to the expanded configuration.

Clause 8. The mitral valve repair device of any one of clauses 1 through7, wherein the extension unit is configured to push at least a portionof a posterior leaflet of the native mitral valve toward the anteriorleaflet of the native mitral valve.

Clause 9. The mitral valve repair device of any one of clauses 1 through8, wherein the extension unit comprises an inflatable bladder within theinner volume and extending the extension unit comprises injecting theblood into the inflatable bladder.

Clause 10. The mitral valve repair device of any one of clauses 1through 9, wherein the frame is configured to, in response to deploymentfrom a delivery catheter, move from a collapsed configuration toward adeployed configuration, and wherein, when in the deployed configuration,the frame is configured to press against an underside of a posteriorleaflet of the native mitral valve.

Clause 11. The mitral valve repair device of any one of clauses 1through 10, wherein the extension unit comprises a plurality ofprojections and a plurality of depressions, each depression beingdisposed between two of the projections, wherein at least some of theprojections are configured to engage an underside of a posterior leafletof the native mitral valve, and wherein at least some of the depressionsare configured to receive chordae tendineae coupled to the underside ofthe posterior leaflet.

Clause 12. A method of repairing a native mitral valve having ananterior leaflet and a posterior leaflet between a left atrium and aleft ventricle, comprising: implanting a mitral valve repair deviceunder the posterior leaflet, wherein the mitral valve repair devicecomprises: a frame defined by a shape memory material; and an extensionunit positioned around at least a portion of the frame, the extensionunit comprising a flexible material configured to move from a contractedconfiguration for delivery to an expanded configuration; and inflating,with blood, an inner volume of the extension unit to move the flexiblematerial from the contracted configuration to the expanded configurationand to extend inwardly toward a central axis of the valve orifice toclose a gap relative to a free edge of an anterior leaflet of a nativemitral valve in the expanded configuration.

Clause 13. The method of clause 12, wherein positioning the mitral valverepair device under the posterior leaflet comprises positioning theextension unit in the contracted configuration under the posteriorleaflet, and wherein inflating the at least one pocket comprisesexpanding the cover to presses against a wider portion of the posteriorleaflet in the expanded configuration relative to the contractedconfiguration.

Clause 14. The method of clause 12 or 13, wherein the method furthercomprises, before inflating the at least one pocket, releasing the framefrom a collapsed configuration such that the frame moves toward adeployed configuration to press against an underside of the posteriorleaflet.

Clause 15. The method of any one of clauses 12 through 14, wherein theextension unit comprises a plurality of projections and a plurality ofdepressions, each depression being disposed between two of theprojections, and wherein inflating the at least one pocket comprisesextending the projections along an underside of the posterior leafletsuch that an upper side of the projections presses against the posteriorleaflet and the chordae tendineae are positioned in at least some of thedepressions.

Clause 16. The method of any one of clauses 12 through 15, whereininflating the at least one pocket further comprises closing a gaprelative to free edges of the posterior leaflet and the anteriorleaflet.

Clause 17. A medical system for repairing a native valve of a patient,the system comprising: a delivery catheter extending from a proximalportion controllable by a clinician to a distal portion introducibleinto a vasculature of a patient; and a valve repair device positionedwithin the distal portion of the delivery catheter, wherein the valverepair device comprises: a frame defined by a shape memory material; andan extension unit positioned around at least a portion of the frame, theextension unit comprising a flexible material configured to move from acontracted configuration for delivery to an expanded configuration, theextension unit having an inner volume configured to be filled with bloodin the expanded configuration, wherein the delivery catheter isconfigured to deploy the valve repair device in the contractedconfiguration into a subannular position behind at least one leaflet ofa native valve connected to chordae tendineae, and wherein the extensionunit, when in the expanded configuration, is configured to extendinwardly toward a central axis of an orifice of the native valve toclose a gap relative to a free edge of the at least one leaflet of thenative valve in the expanded configuration.

Clause 18. The medical system of clause 17, wherein the native valve isa mitral valve, and wherein the heart wall is a left ventricular walland the leaflet is a posterior mitral valve leaflet.

Clause 19. The medical system of clause 17 or 18, wherein the chordaetendineae are basal or tertiary chordae tendineae.

Clause 20. The medical system of any one of clauses 17 through 19,wherein the valve repair device is configured to engage the heart walland the underside of the at least one leaflet without penetrating theheart wall tissue or the leaflet.

What is claimed is:
 1. A mitral valve repair device, comprising: a framecomprising a shape memory material; and an extension unit positionedaround at least a portion of the frame, the extension unit comprising aflexible material configured to move from a contracted configuration fordelivery to an expanded configuration, the extension unit having aninner volume configured to be filled with blood in the expandedconfiguration, and the extension unit configured to extend inwardlytoward a central axis of an orifice of a native mitral valve to close agap relative to a free edge of an anterior leaflet of the native mitralvalve in the expanded configuration.
 2. The mitral valve repair deviceof claim 1, wherein the flexible material comprises a cover, and whereinthe cover is configured to enable tissue ingrowth.
 3. The mitral valverepair device of claim 1, wherein, when in the contracted configuration,the frame and the extension unit are sized to fit within a deliverycatheter.
 4. The mitral valve repair device of claim 1, wherein theextension unit comprises a fluid absorbing material within the innervolume.
 5. The mitral valve repair device of claim 4, wherein the fluidabsorbing material comprises a foam.
 6. The mitral valve repair deviceof claim 4, wherein the fluid absorbing material comprises a hydrogel.7. The mitral valve repair device of claim 4, wherein, when in contactwith the blood, the fluid absorbing material is configured to expand toinflate the extension unit from the contracted configuration to theexpanded configuration.
 8. The mitral valve repair device of claim 1,wherein the extension unit is configured to push at least a portion of aposterior leaflet of the native mitral valve toward the anterior leafletof the native mitral valve.
 9. The mitral valve repair device of claim1, wherein the extension unit comprises an inflatable bladder within theinner volume and extending the extension unit comprises injecting theblood into the inflatable bladder.
 10. The mitral valve repair device ofclaim 1, wherein the frame is configured to, in response to deploymentfrom a delivery catheter, move from a collapsed configuration toward adeployed configuration, and wherein, when in the deployed configuration,the frame is configured to press against an underside of a posteriorleaflet of the native mitral valve.
 11. The mitral valve repair deviceof claim 1, wherein the extension unit comprises a plurality ofprojections and a plurality of depressions, each depression beingdisposed between two of the projections, wherein at least some of theprojections are configured to engage an underside of a posterior leafletof the native mitral valve, and wherein at least some of the depressionsare configured to receive chordae tendineae coupled to the underside ofthe posterior leaflet.
 12. A method of repairing a native mitral valvehaving an anterior leaflet and a posterior leaflet between a left atriumand a left ventricle, comprising: implanting a mitral valve repairdevice under the posterior leaflet, wherein the mitral valve repairdevice comprises: a frame defined by a shape memory material; and anextension unit positioned around at least a portion of the frame, theextension unit comprising a flexible material configured to move from acontracted configuration for delivery to an expanded configuration; andinflating, with blood, an inner volume of the extension unit to move theflexible material from the contracted configuration to the expandedconfiguration and to extend inwardly toward a central axis of the valveorifice to close a gap relative to a free edge of an anterior leaflet ofa native mitral valve in the expanded configuration.
 13. The method ofclaim 12, wherein positioning the mitral valve repair device under theposterior leaflet comprises positioning the extension unit in thecontracted configuration under the posterior leaflet, and whereininflating the at least one pocket comprises expanding the cover topresses against a wider portion of the posterior leaflet in the expandedconfiguration relative to the contracted configuration.
 14. The methodof claim 12, wherein the method further comprises, before inflating theat least one pocket, releasing the frame from a collapsed configurationsuch that the frame moves toward a deployed configuration to pressagainst an underside of the posterior leaflet.
 15. The method of claim12, wherein the extension unit comprises a plurality of projections anda plurality of depressions, each depression being disposed between twoof the projections, and wherein inflating the at least one pocketcomprises extending the projections along an underside of the posteriorleaflet such that an upper side of the projections presses against theposterior leaflet and the chordae tendineae are positioned in at leastsome of the depressions.
 16. The method of claim 12, wherein inflatingthe at least one pocket further comprises closing a gap relative to freeedges of the posterior leaflet and the anterior leaflet.
 17. A medicalsystem for repairing a native valve of a patient, the system comprising:a delivery catheter extending from a proximal portion controllable by aclinician to a distal portion introducible into a vasculature of apatient; and a valve repair device positioned within the distal portionof the delivery catheter, wherein the valve repair device comprises: aframe defined by a shape memory material; and an extension unitpositioned around at least a portion of the frame, the extension unitcomprising a flexible material configured to move from a contractedconfiguration for delivery to an expanded configuration, the extensionunit having an inner volume configured to be filled with blood in theexpanded configuration, wherein the delivery catheter is configured todeploy the valve repair device in the contracted configuration into asubannular position behind at least one leaflet of a native valveconnected to chordae tendineae, and wherein the extension unit, when inthe expanded configuration, is configured to extend inwardly toward acentral axis of an orifice of the native valve to close a gap relativeto a free edge of the at least one leaflet of the native valve in theexpanded configuration.
 18. The medical system of claim 17, wherein thenative valve is a mitral valve, and wherein the heart wall is a leftventricular wall and the leaflet is a posterior mitral valve leaflet.19. The medical system of claim 17, wherein the chordae tendineae arebasal or tertiary chordae tendineae.
 20. The medical system of claim 17,wherein the valve repair device is configured to engage the heart walland the underside of the at least one leaflet without penetrating theheart wall tissue or the leaflet.